REGENXBIO

REGENXBIO, Inc. is a clinical-stage biotechnology company, which engages in the development, commercialization, and licensing of recombinant adeno-associated virus gene therapy. Its product candidates include the NAV Technology Platform, which consists of exclusive rights to novel adeno-associated viral vectors, and therapeutic programs such as RGX-314, RGX-202, RGX-121, RGX-111, RGX-181, and RGX-381. The company was founded by Kenneth T. Mills and James M. Wilson on July 16, 2008 and is headquartered in Rockville, MD.

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REGENXBIO reports robust earnings, eyes gene therapy market expansion

REGENXBIO's Q4 2022 earnings call highlighted strong financial performance, progress in gene therapy development, and strategic collaborations with AbbVie.
While challenges like precise dosing and program validation exist, the company's focus on innovation and market potential present significant growth opportunities.
With a robust pipeline, efficient development processes, and a commitment to addressing unmet medical needs, REGENXBIO is well-positioned for continued success in the gene therapy market.
Investors can look forward to potential revenue growth from royalty recognition and license agreements, supported by the company's solid financial foundation and strategic initiatives.

REGENXBIO reports solid Q1 earnings, advances gene therapy initiatives

REGENXBIO's Q1 2023 earnings call showcased strong financial performance, progress in gene therapy, and strategic partnerships, positioning the company for future growth.
Challenges such as patient exclusions in clinical trials and decision-making on pivotal studies require careful navigation and operational focus.
Opportunities in partnership milestones, regulatory paths, and market differentiation present avenues for continued success and innovation in the gene therapy space.

REGENXBIO advances AAV therapeutics with strong Q2 performance

REGENXBIO's Q2 performance reflects progress in AAV therapeutics and positive clinical outcomes, supported by a strong financial position and strategic focus on urgent medical needs.
While facing challenges related to competitive pressures and program timelines, the company's commitment to innovation and regulatory compliance positions it well for future growth.
Opportunities lie in differentiated treatment approaches, improved product efficacy, and expedited regulatory pathways, signaling potential for market leadership and patient impact.

REGENXBIO reports robust Q3 results, eyes sustainable growth post-2025

REGENXBIO's Q3 2023 earnings call highlighted strong financial performance, clinical progress, and strategic initiatives, showcasing a promising outlook for the company.
While facing challenges in aligning financial expectations and operational performance, REGENXBIO's focus on cost-saving measures and program advancements presents growth opportunities.
The company's commitment to patient impact, regulatory excellence, and shareholder value creation underpin its position as a key player in the biopharmaceutical industry.

REGENXBIO reports robust earnings, focuses on AAV innovation and growth

REGENXBIO's Q4 2023 earnings call highlighted strong financials, exciting program progress, and a focus on innovation in AAV therapeutics for long-term value creation.
While challenges exist in navigating AAV development complexity and operational demands, the company's proactive approach and financial strength position it well for growth.
Opportunities lie in leveraging cash reserves for accelerated development, engaging stakeholders for strategic insights, and exploring enhancements in therapeutic benefits.

REGENXBIO reports strong Q2 results, poised for program advancements

REGENXBIO's Q2 performance showcased advancements in key programs, bolstered by a strong financial position and positive clinical data.
While challenges exist in patient recruitment and regulatory strategies, opportunities for market approvals and portfolio expansion are on the horizon.
Strategic planning and successful execution will be crucial for REGENXBIO to capitalize on its strengths and navigate potential obstacles.

REGENXBIO reports robust Q3 results and advances gene therapy programs

REGENXBIO's strong financial position and progress in key programs demonstrate a promising outlook for the company's growth and innovation.
The company's focus on rare diseases and ophthalmology positions it as a leader in gene therapy treatments with significant market potential.
Addressing challenges related to program durability, market competition, and regulatory complexities will be crucial for sustaining growth and success.

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Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026 Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosed Phase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomes Functional improvements seen in all patients  treated with dose level 1 and dose level 2 at 12 and 9 months respectively New biomarker data confirms consistent robust expression of differentiated RGX-202 microdystrophin in the muscle Favorable safety profile observed at both dose levels; no serious adverse events or AEs of special interest  Webcast to be held at 8:00 a.m. today ROCKVILLE, Md.

REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA

-       Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trial and Michael Kelly, PhD, Chief Scientific Officer of CureDuchenne ROCKVILLE, Md.

REGENXBIO to Host Webcast Discussing Pivotal Program and First Functional Data from the AFFINITY DUCHENNE® Trial of RGX-202

REGENXBIO Inc. (RGNX) Q3 2024 Earnings Call Transcript

Regenxbio (RGNX) came out with a quarterly loss of $1.17 per share versus the Zacks Consensus Estimate of a loss of $1.16. This compares to loss of $1.41 per share a year ago.

Regenxbio (RGNX) Reports Q3 Loss, Tops Revenue Estimates

Advancement in Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this month BLA submission for RGX-121 initiated and expected to complete in Q1 2025 Positive Phase II data support bilateral administration of subretinal ABBV-RGX-314; data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile End-of-Phase II meeting for ABBV-RGX-314 in diabetic retinopathy accelerated to Q4 2024 to support global pivotal program initiation in H1 2025 Conference call today at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates

ROCKVILLE, Md. , Nov. 4, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences: UBS Global Healthcare Conference  Fireside Chat: Wednesday, November 13 at 12:30 p.m.

REGENXBIO to Participate in Upcoming Investor Conferences

Positive updated long-term results from phase I/II/III CAMPSITE study using RGX-121 for the treatment of patients with MPS II. Rolling BLA submission of RGX-121 for the treatment of patients with MPS II expected any day now in Q4 of 2024. The global Hunter Syndrome treatment market is expected to reach $1.78 billion by 2030.

REGENXBIO: With Additional MPS II Data, Program Advancement Remains On Track

ROCKVILLE, Md. , Oct. 30, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, November 6, at 4:30 p.m.

REGENXBIO to Host Conference Call on November 6 to Discuss Third Quarter 2024 Financial Results and Recent Operational Highlights

97% reduction in treatment burden at nine months after treatment with ABBV-RGX-314 Data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile Well tolerated with zero cases of intraocular inflammation in a setting of no prophylactic steroids Data highlight the potential of ABBV-RGX-314 to treat both eyes in wet AMD ROCKVILLE, Md. , Oct. 21, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive data from the Phase II fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD).

REGENXBIO Presents Positive Data from the Phase II Study of Subretinal ABBV-RGX-314 in Patients with Bilateral Wet AMD at AAO 2024

ROCKVILLE, Md. , Oct. 18, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present new interim data evaluating subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD) at the American Academy of Ophthalmology 2024 annual meeting.

REGENXBIO Announces Presentations at the American Academy of Ophthalmology 2024 Annual Meeting

ROCKVILLE, Md. , Sept. 23, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in Chardan's 8th Annual Genetic Medicines Conference on Monday, September 30, 2024.

REGENXBIO to Participate in Chardan's 8th Annual Genetic Medicines Conference

Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programs Vit Vasista steps down following more than 15 years at the Company ROCKVILLE, Md. , Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today.

REGENXBIO Appoints Mitchell Chan as Chief Financial Officer

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-  Data from pivotal dose level demonstrates long-term, sustained reductions in CSF levels of HS D2S6, a key biomarker of brain disease in MPS II -  80% of patients who received the pivotal dose discontinued intravenous enzyme replacement therapy or remained treatment-naïve -  Submission of a rolling BLA using the accelerated approval pathway on track for Q3 2024 ROCKVILLE, Md. , Sept. 3, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for the treatment of patients with Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome.

REGENXBIO Announces Positive Data from Pivotal Dose Level of RGX-121 Demonstrating Long-Term Systemic Effect

ROCKVILLE, Md. , Aug. 27, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced data from its RGX-121 program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the SSIEM 2024 Annual Symposium, taking place in Porto, Portugal from September 3-6, 2024.

REGENXBIO Announces Presentation at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium

ROCKVILLE, Md. , Aug. 8, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the H.C.

REGENXBIO to Participate in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference

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Regenxbio Inc.'s rolling BLA submission of RGX-121 for the treatment of patients with MPS II expected in Q3 of 2024. Additional results from the phase 1/2/3 CAMPSIITE study, using RGX-121 for the treatment of patients with MPS II, expected in the 2nd half of 2024. Initiation of a pivotal study, using RGX-202 for the treatment of patients with Duchenne Muscular Dystrophy, expected in Q4 of 2024.

Regenxbio: RGX-121 Could Achieve A First For Rare Neurodegenerative Disorder

The average of price targets set by Wall Street analysts indicates a potential upside of 234.4% in Regenxbio (RGNX). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Wall Street Analysts Think Regenxbio (RGNX) Could Surge 234.37%: Read This Before Placing a Bet

REGENXBIO Inc. (NASDAQ:RGNX ) Q2 2024 Earnings Conference Call August 1, 2024 4:30 PM ET Company Participants Patrick Christmas - CLO Curran Simpson - President and CEO Steve Pakola - CMO Vit Vasista - CFO Conference Call Participants Gena Wang - Barclays Vikram Purohit - Morgan Stanley Paul Choi - Goldman Sachs Annabel Samimy - Stifel C.J. Yeh - Leerink Partners Luca Issi - RBC Brian Skorney - Baird Daniil Gataulin - Chardan Capital Markets Operator Welcome everyone to the Q2 2024 REGENXBIO's Earnings Conference Call.

REGENXBIO Inc. (RGNX) Q2 2024 Earnings Call Transcript

Regenxbio (RGNX) came out with a quarterly loss of $1.05 per share versus the Zacks Consensus Estimate of a loss of $1.29. This compares to loss of $1.66 per share a year ago.

Regenxbio (RGNX) Reports Q2 Loss, Tops Revenue Estimates

Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for Duchenne (H2 2024) and diabetic retinopathy (H1 2025) New, positive data from Phase II AFFINITY DUCHENNE® trial of RGX-202 demonstrates consistent high expression of microdystrophin across treated patients in all age groups Successful End-of-Phase II meeting with FDA for RGX-202 supports plans for using the accelerated approval pathway and pivotal initiation in Q4 2024 End-of-Phase II meeting for ABBV-RGX-314 for diabetic retinopathy accelerated to Q4 2024 to support global pivotal program initiation in H1 2025 $327 million in cash, cash equivalents and marketable securities as of June 30, 2024, expected to fund operational runway into 2026 Conference call Thursday, August 1, at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports Second Quarter 2024 Financial Results and Recent Operational Highlights

Robust microdystrophin expression observed in new data from pivotal dose Patients aged 5.8 and 8.5 years at dosing had expression levels at 77.2% and 46.5% of control, respectively Consistent high expression of microdystrophin across treated patients in all age groups continues to support plans for accelerated approval Expects to initiate pivotal trial in Q4 2024 ROCKVILLE, Md. , Aug. 1, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today reported new, positive interim safety and efficacy data in the Phase I/II AFFINITY DUCHENNE® trial of RGX-202 in patients with Duchenne muscular dystrophy (Duchenne) ages 1 to 11 years old.

REGENXBIO ANNOUNCES NEW POSITIVE DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202

ROCKVILLE, Md. , July 25, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Thursday, August 1, 2024, at 4:30 p.m.

REGENXBIO to Host Conference Call on August 1 to Discuss Second Quarter 2024 Financial Results and Recent Operational Highlights

Regenxbio (RGNX) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

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